WO2021058465A1 - Électrode d'aspiration - Google Patents

Électrode d'aspiration Download PDF

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Publication number
WO2021058465A1
WO2021058465A1 PCT/EP2020/076402 EP2020076402W WO2021058465A1 WO 2021058465 A1 WO2021058465 A1 WO 2021058465A1 EP 2020076402 W EP2020076402 W EP 2020076402W WO 2021058465 A1 WO2021058465 A1 WO 2021058465A1
Authority
WO
WIPO (PCT)
Prior art keywords
electrode
suction
base part
head
electrode according
Prior art date
Application number
PCT/EP2020/076402
Other languages
German (de)
English (en)
Inventor
Manuel BUCHER
Original Assignee
Mbnet Ag
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Mbnet Ag filed Critical Mbnet Ag
Priority to EP20772318.0A priority Critical patent/EP4033976A1/fr
Publication of WO2021058465A1 publication Critical patent/WO2021058465A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/251—Means for maintaining electrode contact with the body
    • A61B5/252—Means for maintaining electrode contact with the body by suction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02—Operational features
    • A61B2560/0266—Operational features for monitoring or limiting apparatus function
    • A61B2560/028—Arrangements to prevent overuse, e.g. by counting the number of uses
    • A61B2560/0285—Apparatus for single use
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/12—Manufacturing methods specially adapted for producing sensors for in-vivo measurements
    • A61B2562/125—Manufacturing methods specially adapted for producing sensors for in-vivo measurements characterised by the manufacture of electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/291—Bioelectric electrodes therefor specially adapted for particular uses for electroencephalography [EEG]

Definitions

  • Suction electrodes are used in biomedicine, for example to create an EKG (electrocardiogram) or to create an EEG (electroencephalogram). Thanks to a weak negative pressure applied, they have improved skin contact and thus guarantee more optimal measurements.
  • Such suction electrodes are well known in the prior art. For reasons of hygiene, but also for quality assurance of the measurement, it is advantageous if electrodes are replaced after a single use.
  • suction electrodes are relatively expensive to manufacture. It is therefore known to divide the suction electrode into a reusable base part and a disposable electrode body.
  • Such a suction electrode is disclosed, for example, in EP 0 143 761 B1.
  • This suction electrode has an electrode plate, a suction head and a connection part with a suction connection.
  • the electrode plate and the suction head form the disposable part, which is disposed of after first use.
  • the connection part forms the base part.
  • the electrode plate has a head which is inserted into the connector through the suction head and thus holds the suction electrode together.
  • Suction channels lead from the connection part through the suction head to the electrode.
  • the suction head has a circumferential outer and a circumferential inner sealing lip.
  • the outer sealing lip seals a skin surface of the patient surrounding the electrode from the outside.
  • the inner sealing lip presses sealingly onto the electrode plate from above.
  • the middle area of the suction electrode and thus the electrode plate is pressed towards the skin.
  • the inner sealing lip bends radially outwards and is raised, creating a suction channel is opened between the interior of the intermediate part and the connecting part.
  • EP 0 626 820 B1, EP 0 729 316 B1, EP 0 744 911 B1 and EP 3 011 900 A1 likewise describe suction electrodes with a part that is disposable after a single use and a reusable part.
  • the disposable part has a dirt absorber.
  • the suction electrode according to the invention has a base part and an electrode body.
  • An electrode with an electrode foot for resting on a patient's skin is either part of the electrode body or the base part.
  • the electrode body can be connected to the base part in a detachable and airtight manner.
  • the electrode body has a suction head with an interior space in which the electrode base is located.
  • the suction head has a circumferential outer sealing lip to rest on the patient's skin and a circumferential inner sealing lip which rests sealingly on a circumferential lateral lateral surface of the electrode foot or on a circumferential lateral lateral surface of an annular body surrounding the electrode foot in an airtight manner.
  • the inner sealing lip releases the lateral surface at least partially by means of axial pressure on the base part, preferably completely free, in order to create a suction connection between an interior space of the suction head and the base part.
  • the electrode is part of the electrode body, it is preferably disposed of with the electrode body. It is therefore preferably intended for single use.
  • the electrode is part of the base part, it can preferably can be reused and it is not used once with the electrode body and then disposed of.
  • the electrode foot is designed as an electrode plate, preferably with a planar contact surface.
  • the electrode foot has a different shape. It is preferably elongated, preferably essentially rod-shaped or pin-shaped. It preferably has a rounded free end. The free end of the pin-shaped electrode can, however, also have a different shape, in which case it preferably offers an approximately point-shaped contact surface for resting on the skin surface of the patient.
  • the elongated, in particular the rod-shaped or pin-shaped electrode is suitable for integration in the base part and thus for multiple use of the suction electrode, which is otherwise designed for single use.
  • the minimized contact surface for resting on the patient's skin, especially when the free end of the electrode is rounded, enables a low risk of contamination and sufficient cleaning options so that the base part can be used several times.
  • the cleaning of the elongated electrode is easier if the electrode is part of the base part and the electrode body has been removed. This makes the electrode more accessible for cleaning.
  • the elongate electrode preferably has at least one constriction or widening along its longitudinal axis for sealing connection with the base part and / or the suction head.
  • a signal cable of an electrode tube is preferably attached to the electrode.
  • the suction head also known as the suction dome
  • the suction head can be designed in a simple form thanks to the inner sealing lip lying on the side. This reduces the manufacturing cost.
  • the lateral contact of the inner sealing lip optimizes the functionality of this seal, which acts as a valve.
  • the valve can open in a circle and thus prevents the suction electrode from shifting on the patient's skin, in particular if the electrode foot is designed in the form of a plate.
  • the electrode has an electrode head that the Interspersed suction head.
  • the base part has an electrode holder for detachably holding the electrode head for the purpose of connecting the electrode body to the base part.
  • the electrode itself ensures the connection between the electrode body and the base part. This reduces the number of components required and thus the manufacturing costs.
  • the electrode body preferably has an annular sealing surface directed towards the base part and the base part has a counter-sealing surface directed towards the electrode body.
  • the sealing surface and the counter-sealing surface jointly seal the connection between the base part and the electrode body to the outside.
  • the sealing surface and the counter-sealing surface can be designed to be flat. This makes production easier and reduces costs.
  • the suction head preferably has a central recess which is surrounded by the inner sealing lip, a receiving opening, preferably a through opening, for the electrode being present in the recess, for example in a bottom of the recess.
  • a receiving opening preferably a through opening
  • suction openings in a circumferential side wall of the recess. This is also a relatively simple and uncomplicated design, which thus facilitates production.
  • annular sealing surface is arranged in the central recess and it surrounds the suction openings, an optimal seal has been created in a simple manner. It is also advantageous that the annular sealing surface must have a relatively small diameter. There only needs to be space for the receiving opening for the electrode head and the suction openings in the interior of the sealing ring. Thanks to the small size, the sealing effect is increased and the risk that the connection between the base part and the electrode body is not tight is minimized. This idea is claimed as a separate invention, detached from the design of the two sealing lips of the suction head, in particular in relation to the electrode.
  • the suction head is preferably at least partially, preferably entirely flexible. It is preferably made of silicone. In preferred embodiments it is formed in one piece.
  • the suction head has an essentially circular-cylindrical base body.
  • the outer sealing lip preferably forms a circumferential inner surface which runs parallel to a central longitudinal axis of the suction electrode. It preferably tapers towards the free end. This training ensures a tight fit on the skin of a patient.
  • the inner sealing lip is preferably designed to run obliquely towards a longitudinal center axis of the suction electrode towards its free end. It can thus lie tightly against the side surface under prestress.
  • the base part has an insert part with a suction connection for connection to an external suction source, with a central suction chamber and with suction channels.
  • the suction channels lead from an outer side of the insert part facing the electrode body to the suction chamber and the suction connection leads into the suction chamber. This enables a compact design of the base part.
  • the insert part is preferably designed to be rigid or semi-rigid and preferably made of plastic. It can be manufactured at a low cost. Most preferred is the stiff design.
  • the insert part is preferably designed to be open on a side opposite the electrode body.
  • the suction electrode has a cover which closes the insert part airtight except for the suction connection and the vacuum channels. Thanks to the open design, a connection between a signal cable connection and an electrically conductive connection element to the electrode head can be established relatively quickly and with simple means during the manufacture of the suction electrode. Access for a soldering point is also given, provided that the connection is made by soldering at all.
  • the cover can also be designed in different colors in order to create a distinguishing feature.
  • the remaining parts of the suction electrodes can be designed in the same way for different areas to be used. Since larger numbers of the basic components can be manufactured in this way, the manufacturing costs are also minimized here.
  • the sheath can be easily attached to the insert part if it is designed to be flexible.
  • the insert part preferably has a substantially circular cylindrical shape Base body with a radially outwardly projecting circumferential flange.
  • the casing has an essentially circular cylindrical base body with a circumferential sealing groove directed radially inward, the sealing groove sealingly surrounding the flange.
  • the shell therefore only has to be slipped over the insert part in order to complete the base part and to sufficiently seal the interior space. This idea is claimed as a separate invention, detached from the design of the two sealing lips of the suction head, in particular in relation to the electrode.
  • the base part has an electrode holder made of an electrically conductive material.
  • This electrode holder is designed as a separate component and has a dome directed into the base part for contacting a signal cable.
  • the electrode holder and the electrode are mostly formed from a non-conductive material and provided with electrically conductive properties by means of coating, doping or other means.
  • the remaining parts are preferably inexpensive, rigid plastic parts or flexible silicone bodies. The minimization of the metal content increases the measurement accuracy and lowers the manufacturing costs.
  • the electrode body according to the invention of a suction electrode according to the invention described above has at least the suction head and the electrode.
  • this disposable electrode body which is intended for single use, consists only of these two parts.
  • the electrode body has, in addition to or instead of the electrode, an annular body which bridges a distance between the electrode foot of the electrode, preferably the electrode plate or the rod-shaped or pin-shaped rounded end part, and the inner sealing lip, so that the inner sealing lip forms a seal the outer surface of this ring body rests.
  • the ring body preferably has a circumferential inner support edge for sealing support of the electrode foot.
  • the ring body can be designed, for example, as a flat ring or as a body with a U-shaped cross section. It is preferably made of plastic. This allows the area of the electrode foot, in particular of the electrode plate or of the rod-shaped or pin-shaped rounded end part, to be minimized.
  • the metal content is also minimized and manufacturing costs are reduced.
  • the ring body is preferably made rigid. It can also be made semi-rigid or soft or at least partially semi-rigid or soft. If the ring body is provided on its underside facing the patient's skin with a circumferential, downwardly protruding edge, for example a lip or a bead, this increases the quality of the measurement. The reason for this is that this circumferential edge fixes the skin around the contact surface of the electrode in its position, so that when the patient moves, even if the outer sealing lip does not sufficiently stabilize the skin, the area around the contact surface remains unchanged.
  • the electrode body intended for single use consists exclusively of
  • the suction electrode consists of a base part and an electrode body, the base part and the electrode body jointly consisting of a. a one-piece insert with a connecting piece for connection to an electrode tube, b. a one-piece sheath for closing the insert part, c. a one-piece electrode having one end for contacting a skin surface of the patient and for connecting the base part to the electrode body, d. a one-piece suction head which surrounds the end and which rests sealingly on the skin surface of the patient, and e. a one-piece electrode holder for holding the electrode and / or an annular body surrounding the electrode.
  • the electrode body consists of the electrode and the suction head. In another preferred embodiment, the electrode body consists of the electrode, the ring body and the suction head. In a variant of these embodiments, the electrode holder is present and arranged in the base part, the electrode being releasably insertable into the electrode holder. In these or alternative variants, the electrode is a stamp electrode or an elongated electrode is trained.
  • the electrode body consists of the ring body and the suction head. Preferably there is no electrode holder.
  • the electrode is preferably designed as an elongated electrode.
  • the insert and, if present, the ring body are rigid and made of plastic.
  • the casing and the suction head are flexible and made of plastic and the electrode and, if present, the electrode holder are made of an electrically conductive metal or they are provided with an electrically conductive layer.
  • suction electrodes consist of a minimum of individual parts and are therefore inexpensive to manufacture.
  • the structure according to the invention and the shape of the individual parts of the suction electrode reduce the manufacturing costs of the entire device. In addition, especially the production costs for the electrode body intended for single use can be kept relatively low.
  • FIG. 1 shows a perspective view of a suction electrode according to the invention in a first embodiment
  • FIG. 2 shows a perspective view of the suction electrode according to FIG. 1 from below;
  • Figure 3 is a side view of the suction electrode according to Figure 1 in a
  • FIG. 4 shows a longitudinal section through the suction electrode according to FIG. 1 in an exploded view
  • FIG. 5 shows a further side view of the suction electrode according to FIG. 1 in an exploded view with interior areas shown in dashed lines;
  • FIG. 6 shows a longitudinal section through the suction electrode according to FIG. 1 in the idle state with the inner sealing lip closed
  • FIG. 7 shows a longitudinal section through the suction electrode according to FIG. 1 in the state of use with an open inner sealing lip
  • FIG. 8 shows a perspective illustration of an electrode of the suction electrode according to FIG. 1;
  • FIG. 9a shows a perspective illustration of a suction head of the suction electrode according to FIG. 1;
  • FIG. 9b shows a further perspective illustration of the suction head according to FIG. 9a;
  • FIG. 10 shows a perspective illustration of an electrode holder of the suction electrode according to FIG. 1;
  • FIG. 11a shows a view of an insert part of the suction electrode according to FIG. 1 from above;
  • FIG. 11 b shows a view of the insert part according to FIG. 11 a from below;
  • FIG. 11 c a perspective view of the insert part according to FIG. 11 a;
  • FIG. 12 shows a perspective illustration of a casing of the suction electrode according to FIG. 1;
  • FIG. 13 shows a perspective view of the suction electrode according to the invention from below according to a second embodiment
  • FIG. 14 shows a longitudinal section through the suction electrode according to FIG. 13 in an exploded view
  • FIG. 15 shows a longitudinal section through a suction electrode according to the invention according to a third embodiment in an exploded view
  • FIG. 16a shows a perspective view of an insert part of the suction electrode according to the invention according to FIG. 15 from above;
  • FIG. 16b shows a view of the insert part according to FIG. 16a from above;
  • FIG. 17a shows a side view of an electrode of the suction electrode according to FIG. 15;
  • FIG. 17b shows a perspective view of the electrode according to FIG. 17a
  • FIG. 18a shows a side view of the suction head of the suction electrode according to FIG. 15;
  • FIG. 18b shows a perspective view of the suction head according to FIG. 18a from above
  • FIG. 18c shows a perspective view of the suction head according to FIG. 18a from below
  • FIG. 19a shows a perspective view of an annular body of the suction electrode according to FIG. 15 from above;
  • FIG. 19b shows a perspective view of the ring body according to FIG. 19a from below and FIG. 20 shows a longitudinal section through the suction electrode according to FIG. 15.
  • a first embodiment of the suction electrode according to the invention is shown. It can be used in particular for EKG, preferably also for EEG or for other biomedical measurements.
  • the suction electrode has a base part A and an electrode body B.
  • the electrode body B can be detachably plugged into the base part A for the use of the suction electrode.
  • the electrode body B is designed as a disposable part and is preferably disposed of after it has been used for the first time.
  • the base part A is intended and designed for multiple use.
  • the base part A can be connected to a known type of vacuum pump. It has an electrode tube 6 for this purpose.
  • the hose 6 is preferably firmly connected to the rest of the base part A. In other embodiments, it is detachable from the rest of the base part A. attachable.
  • the suction hose 6 has a jacket 60 which merges in one piece into a sleeve 600 at one end.
  • the sleeve 600 can be slipped over a connection piece 21 of the base part A or, depending on the diameter ratio, pushed into it.
  • the suction hose 6 has a suction lumen 62 for applying a negative pressure inside the base part A.
  • a signal cable 61 runs in the suction lumen 62 for transmitting the measurement signals to an evaluation unit (not shown), for example an EKG device.
  • An end piece 610 of the signal cable 61 is bent in this example. This can be seen clearly in FIGS. 3 to 5. However, it can also be designed in other known ways.
  • the base part A here comprises a cover 1, an insert part 2 and an electrode holder 3.
  • the cover 1 is preferably made from a soft, in particular from a flexible material. For example, it is made of silicone.
  • the insert 2 is rigid. It is preferably made of plastic.
  • the electrode holder 3 is made of an electrically conductive material, in particular metal.
  • the electrode body B consists of a suction head 4 and an electrode 5.
  • the suction head 4 is preferably made of a soft, in particular an elastic, material. It is preferably made of silicone.
  • the electrode 5 is made of an electrically conductive material, preferably metal. Alternatively, it is designed to be electrically conductive at least on its surface, for example by means of a coating.
  • the electrode holder 3 can also only be provided with a corresponding conductive coating.
  • the suction head 4 and the electrode 5 are preferably designed in one piece for themselves.
  • FIGS. 8 to 12 The individual components of the suction electrode according to the invention are shown individually in FIGS. 8 to 12.
  • FIG. 8 shows the electrode 5.
  • it is designed as a so-called stamp electrode.
  • it has a base body in the form of an electrode plate 50 with a flat surface 51.
  • the flat surface forms a contact surface for resting on the skin of a patient.
  • the planar surface 51 can be clearly seen in FIG.
  • An electrode head 52 is formed on the electrode plate 50.
  • FIGS. 9 a and 9 b show the suction head 4. It has a cylindrical base body 40 which is designed to be open on one side and ends in a circumferential outer sealing lip 41. The opposite side of the base body 40 is designed to be closed except for a central receiving opening 43 and suction openings 45. The central receiving opening 43 and the suction openings 45 are located in a central depression 44, also called a trough.
  • the recess 44 is dome-shaped, frustoconical or in another shape, preferably tapering downward and inward.
  • the recess 44 On its upper edge facing the base part A, the recess 44 has a step 46 which forms a horizontally running sealing surface 47.
  • a raised, closed spacer ring 48 adjoins the recess 44 when viewed radially outward.
  • the suction openings 45 are present in the inclined area of the recess 44.
  • Their diameter is preferably many times smaller than the diameter of the receiving opening 43.
  • the base body 40 of the suction head 4 defines an interior space 49.
  • a circumferential inner sealing lip 42 projects into this interior space 49. It preferably directly adjoins the dome-shaped recess 44.
  • the inner sealing lip 42 preferably ends with its free end at the same height as the lowermost outer side of the recess 44 protruding into the interior.
  • the receiving opening 43 is preferably located at this point.
  • the inner sealing lip 42 preferably tapers towards its free end, preferably on its outside. In addition, it is preferably inclined towards the longitudinal center axis L of the suction electrode.
  • the outer sealing lip 41 also preferably tapers towards its free end. It extends with its inside preferably parallel to the longitudinal center axis L of the suction electrode and is therefore not inclined. The tapering takes place preferably on its outside, ie over the outer side wall.
  • the outer sealing lip 41 preferably projects beyond the inner sealing lip 42 in the longitudinal direction L of the suction electrode, preferably by at least half the height of the suction head 4.
  • the electrode holder 3 is shown in FIG. 10 and can also be seen clearly in FIGS. 3 to 5.
  • the electrode receptacle 3 has a base 30 with a receptacle opening 32 and a dome 31. In contrast to the receiving opening 43 of the suction head 4, the receiving opening 32 is not continuous, but is preferably designed as a blind hole.
  • At least one retaining element 33 for example a clip or a spring part, is preferably arranged in the receiving opening 32 of the electrode receptacle 3. Two such retaining elements 33 are preferably provided diagonally to one another.
  • FIGS. 11a to 11c show the insert 2. It has a cylindrical base body 20 which is designed to be closed on one end face except for a central receiving opening 25 and openings for suction channels 23, 24.
  • the closed jacket of the insert part 2 is surrounded by a flange 22 protruding radially outward.
  • the receiving opening 25 is surrounded by a circumferential step 26 which forms a counter-sealing surface 27.
  • the counter-sealing surface 27 can be seen in FIGS. 3 and 11b, the step 26 in FIGS. 3 and 4.
  • the opposite end face of the base body 20 is designed to be open.
  • the interior of the base body 20 is reinforced by means of webs 29. They enclose a suction chamber 28 which opens into the receiving opening 25.
  • the first suction channels 23 open into the suction chamber 28.
  • the connecting piece 21, which creates a connection from the suction hose 6 to the suction chamber 28, is molded onto the jacket of the base body 20.
  • the second suction channel 24 is arranged in the area of this connecting piece 21. It is made shorter than the two first suction channels 23 and thus enables the connection between the suction connection 21 and the suction chamber 28. Thanks to this design, the area that has to be subjected to a vacuum within the base part A is minimized.
  • the shell 1 is shown. It has a jacket 10 with a through opening 11.
  • the casing 1 is designed to be open on one end face and has a receiving opening 13.
  • the jacket ends on this free side in an inwardly protruding sealing groove 16.
  • the opposite end face is designed to be closed.
  • the shell 1 thus has the shape of a cap with an interior 12.
  • the closed end face preferably has a recess 14 into which a marking 15 in the form of a round, flat plate can be inserted.
  • the small plate can, for example, have an inscription and / or color coding.
  • the suction electrode is shown in the assembled state. In the illustration according to FIG. 6, the suction electrode is shown in the idle state, in FIG. 7 during use.
  • the electrode head 52 penetrates the receiving opening 43 of the suction head 4. It is held in the receiving opening 32 of the electrode receptacle 3 in a detachable, preferably clamping manner.
  • the tip 31 of the electrode holder 3 is contacted by an end piece 610 of the signal cable 61.
  • the end 610 can also be soldered onto the dome 31.
  • the sheath 1 is pushed onto the insert part 2.
  • the sealing groove 16 of the casing 1 engages around the flange 22 of the insert part 2 and thus seals the insert part 2 from the outside in an airtight manner.
  • the step 26 with the counter-sealing surface 27 of the insert part 2 forms, together with the step 46 and the sealing surface 47 of the suction head, a further circumferential seal.
  • the suction channels 23, 24 of the insert 2 end within this sealing ring and the suction openings 45 of the suction head 4 are also located. The connection between suction channels 23, 24 and suction openings 45 is thus also closed airtight from the outside.
  • the inner sealing lip 42 rests in a sealing manner on the side surface of the electrode plate 50, i.e. on the jacket of the electrode plate 50.
  • the connection between the interior space 49 of the suction head 4 and the suction openings 45 is interrupted.
  • the valve, formed by the inner sealing lip 42 and the outer surface of the electrode plate 50, is closed.
  • a vacuum pump (not shown) is used to apply negative pressure to the suction chamber 28 of the insert part 2 via the electrode hose 6.
  • the suction electrode is then lightly pressed onto the patient's skin by the user pressing on the cover 1.
  • the outer sealing lips 41 seal the covered skin area from the outside.
  • the electrode 5 is pressed onto the patient's skin.
  • the dome-shaped recess 44 of the suction head 4 is also moved axially downwards.
  • the inner sealing lip 42 is bent slightly outwards and thus exposes the valve seat, ie the outer surface of the electrode plate 50. The passage between the interior 49 of the suction head 4 and the suction openings 45 is released.
  • the negative pressure that previously only prevailed in the suction chamber 28 of the insert part 2 is now also in the interior 49 of the suction head 4 created.
  • the valve remains open. The user can now set the negative pressure on the vacuum pump in such a way that the suction electrode is held in its position, but the suction effect is still pleasant for the patient and in particular does not produce any hematomas or painful marks on the skin.
  • the suction electrode can be removed from the skin, for example after use, either by manually grasping it in the area of the outer sealing lip 41 of the suction head 4 or by actuating a blow-out function of the vacuum pump. In the latter case, the suction electrode falls off by itself.
  • FIGS. 13 and 14 A second exemplary embodiment is shown in FIGS. 13 and 14.
  • the suction electrode basically has the same structure and the same parts as the suction electrode according to FIGS. 1 to 12. The same parts are therefore given the same reference numerals. Missing reference symbols can be assigned in a simple manner by comparing the figures.
  • the electrode 5 is, however, made smaller in this example.
  • the ring 7 has in its inner opening a flange 70 protruding radially inwards in order to rest on the electrode plate 50 of the electrode 5 and to be carried by the latter.
  • the ring 7 has an outer jacket with a side surface on which the inner sealing lip 42 rests in a sealing manner and protrudes when negative pressure is applied.
  • FIGS. 15 to 20 A third embodiment of the suction electrode according to the invention is shown in FIGS. 15 to 20.
  • the structure is essentially the same as in the examples described above.
  • the same reference numbers are therefore given for the same parts. Unless specific differences are indicated below, the above description also applies to this exemplary embodiment.
  • This embodiment also has a base part A and an electrode body B.
  • the electrode 5 is held in the reusable base part A and is also reused. It is preferably held fixed therein.
  • the electrode is shaped and / or held firmly in place in the insert.
  • the electrode 5 can be designed differently. Preferably, as shown here, it is elongated. It is preferably designed essentially in the shape of a rod or pin. This has the advantage that relatively little metal has to be used and thus the costs are minimized. A further reduction in costs is that the electrode 5 is not arranged in the disposable part, i.e. in the electrode body B. This allows the manufacturing costs of this disposable part to be minimized.
  • the suction electrode consists of a minimum of individual parts and, in particular, has a very low metal content.
  • the electrode 5 is arranged in the insert part 2 and is preferably held in a fixed manner. It is used to connect to the suction head 4, which can be detachably connected to the electrode 5.
  • the suction head 4 can preferably be plugged onto the electrode 5 and also removed therefrom again.
  • the suction head 4 is preferably attached to the electrode together with the ring body 7 and removed from it again. This removal is preferably carried out non-destructively, at least for the base part A, so that it can be reused.
  • the electrode body B is destroyed during removal in such a way that a new connection to the base part is no longer possible. In other embodiments, reconnection is still possible.
  • the base part A has the insert part 2, which is preferably of rigid design, the sheath 1, which is preferably of flexible design, and, as mentioned above, the electrode 5.
  • the sheath 1 encloses the insert part 2 in a sealing manner.
  • the connection piece 21 serves to connect to an electrode tube 6, not shown here. Reference is made to the description of the first embodiment.
  • the insert part 2 is shown in FIGS. 16a and 16, it is designed essentially the same as the insert part 2 of the two embodiments described above. It is therefore no longer described in detail.
  • the shell 1 shown in Figures 15 and 20 is formed identically or at least similarly.
  • the electrode 5 is shown in detail in FIGS. 17a and 17b. It is preferably formed in one piece. It is preferably made entirely of metal or another electrically conductive material. Alternatively, it has, for example, a non-conductive core and a conductive outer coating. It has a pin-shaped electrode head 53. It is preferably designed in the shape of a cylinder. It protrudes into the suction chamber 28 of the insert part 2 and serves to connect to the electrode tube 6. This can be seen in FIG. In order to establish the connection, the end piece 610 of the signal cable 61 of the electrode tube 6, as can be seen in FIGS. 6 and 7, makes contact with the electrode head 53. It is preferably soldered to it.
  • the signal cable 61 is preferably wound around the electrode head 53 at least once. As a result, a pull or tear protection is formed, which prevents the electrode tube 6 from being torn out of the insert part 2 of the suction electrode.
  • the electrode 5 penetrates the receiving opening 25 of the insert part 2, and is preferably held therein in a fixed manner. For example, it is glued in or welded into it.
  • the electrode 5 has the said electrode head 53, to which a circumferential, radially protruding flange 54 adjoins.
  • the preferably flat underside 541 of the flange 54 rests on a circumferential, recessed step 250 of the receiving opening 25 of the insert part 2.
  • the opposite upper side 540 of the flange 54 is preferably also of planar design and is preferably aligned with the upper edge of the receiving opening 25.
  • the flange 54 is in turn adjoined by a pin-shaped, preferably cylindrical, central region 55. Its diameter is preferably larger than the diameter of the electrode head 53.
  • the middle area 55 merges with a preferably flat step 550 into an intermediate area 56.
  • the intermediate area 56 preferably has a smaller diameter than the central area 55, but preferably a larger diameter than the electrode head 53.
  • the intermediate area 56 and the step 550 do not necessarily have to be present.
  • the intermediate region 56 if present, is preferably designed in the shape of a pin and even more preferably in the shape of a cylinder.
  • the electrode base 58 adjoins this intermediate area 56, preferably via a radially outwardly protruding border 57.
  • This border 57 preferably runs inclined downwards.
  • the electrode foot 58 forms the lower free end of the electrode 5. It protrudes into the interior 49 of the suction head 4. At its lowest end, it forms a contact surface for resting on the patient's skin. This contact area is preferably minimized. It is optimally minimized if the electrode foot 58 is rounded, as shown here. It preferably has the shape of a hemisphere or part of a sphere. However, other shapes, preferably rounded shapes, are also possible.
  • the middle area 55 penetrates the receiving opening 25 of the insert part 2.
  • the underside of the step 550 is preferably aligned with the lower edge of the receiving opening 25.
  • the intermediate area 56 and the electrode base 58 preferably protrude from the intermediate part 2.
  • the receiving opening 25 of the insert part 2 has a smaller diameter than its suction chamber 28.
  • a first step 251 thus separates the receiving opening 25 from the suction chamber 28, as can be seen in FIG.
  • a second step 250 tapers the receiving opening 25 in the upper area. The underside 541 of the electrode 5 rests on this second step 250.
  • the suction head 4 is designed similarly to the previous examples. It is preferably partially or more preferably completely made of a soft and / or flexible material. In particular, it is made of silicone. It is preferably designed in one piece.
  • the suction head 4 is shown in FIGS. 18a, 18b and 18c. It has the cylindrical base body 40 with the interior space 49, the outer sealing lip 41 and the inner sealing lip 42.
  • the two sealing lips 41, 42 are shaped identically or at least similarly as in the previous examples.
  • the inner sealing lip 42 also protrudes into the interior space 49 here.
  • This suction head 4 also preferably has the central dome-shaped depression 44, also called a trough.
  • the step 46 which forms the horizontally running sealing surface 47, is formed on its upper edge.
  • the raised spacer ring 48 is also available. In the inclined region of the recess 44, the suction openings 45 and the receiving opening 43 are arranged centrally.
  • a further sealing surface is preferably produced by a planar surface which is directed upwards towards the base part and which surrounds the receiving opening 43 of the suction head 4. It forms an inner sealing surface 470 opposite a planar, downwardly directed surface which surrounds the receiving opening 25 of the insert part 5 and which forms an inner counter-sealing surface 270.
  • the receiving opening 43 of the suction head 4 is penetrated by the electrode 5, preferably by the intermediate area 56 and the electrode base 58.
  • the receiving opening 43 is correspondingly stepped so that, as can be clearly seen in FIG. 20, it rests on the border 57. Thanks to this resting, the suction head 4 is releasably fixed on the base part A.
  • the step 430 within the receiving opening 43 is preferably designed to run obliquely downward, matching the obliquely downwardly extending border 57 of the electrode 5. This makes it easier to click in and release the suction head 4 from the base part.
  • the recess 44 of the suction head 4 is stepped in this example, a first truncated cone 440 merges into a second truncated cone 441 via an annular groove 442 that is open at the bottom.
  • the second truncated cone 441 preferably projects downward from the first truncated cone 440. In other embodiments they are flush with one another. Both end in a flat, downwardly directed surface running perpendicular to the central longitudinal axis.
  • the inner truncated cone 441 is penetrated by the receiving opening 43.
  • the ring body 7 is also attached to the suction head 4.
  • the ring body 7 is shown in detail in FIGS. 19a and 19b.
  • it is preferably a body with an annular base plate 71 with a central through opening 72 with an upwardly projecting collar 720 surrounding the through opening 72 all the way around.
  • the base plate 71 is surrounded by a circumferential, upwardly directed jacket 73, which is preferably higher than the inner collar 720.
  • the jacket 73 has at least one recess 730.
  • a plurality of recesses 730 are preferably distributed over the circumference. This can be clearly seen in FIG. As can also be seen in FIG.
  • the wall of the recess 44 of the suction head 4 has the circular groove 442 which is open at the bottom.
  • this groove 442 serves to receive the circular inner collar 720 of the ring body 7.
  • the inner, second truncated cone 441 has a sealing bead 443 protruding radially outward, which can be clearly seen in FIG. This rests against the inside of the ring body 7 in a clamping manner. Thanks to these two measures, the ring body 7 is held fixed in the suction head 4.
  • the ring body 7 preferably rests against the lower surface of the outer first truncated cone 440.
  • the inner collar 720 of the ring body 7 is held in the receiving opening 43 and the pin-shaped electrode 5 rests on the inner wall of the collar 720 of the ring body 7.
  • the recess 44 of the suction head 4 is preferably rigid or semi-rigid in order to receive the inner collar 720 in a fixed manner.
  • the outer and inner sealing lips 41, 42 are still designed to be soft.
  • This suction head 4 is preferably also formed in one piece.
  • the electrode foot 58 penetrates the central through opening 72 of the ring body 7 and preferably projects slightly from the underside of the base plate 71.
  • the inner sealing lip 42 lies against the outside of the jacket 73 of the annular body 7 in a sealing manner.
  • the suction electrode according to this third exemplary embodiment is also lightly pressed onto the patient's skin during use, in that the user presses on the cover 1.
  • the outer sealing lips 41 seal the covered skin area from the outside. This axial contact pressure presses the electrode base 58 onto the patient's skin.
  • the dome-shaped recess 44 of the suction head 4 is also moved axially downwards.
  • the inner sealing lip 42 is bent slightly outwards and thus exposes the valve seat, i.e. the outside of the casing 73 of the annular body 7.
  • the passage between the interior 49 of the suction head 4 and the suction openings 45 is released. The opening of the passage is ensured if, as in this example, recesses 730 are preferably present in the jacket 73.
  • the negative pressure previously only prevailing in the suction chamber 28 of the insert part 2 is now also applied in the interior 49 of the suction head 4.
  • the valve remains open. The user can now set the negative pressure on the vacuum pump in such a way that the suction electrode is held in its position, but the suction is still pleasant for the patient and in particular does not produce any hematomas or painful marks on the skin.
  • the measurement is also improved thanks to a downwardly projecting circumferential projection 710 of the ring body 7.
  • This projection 710 is preferably formed in an annular manner. It can be designed, for example, as a lip protruding downwards or as a bead. It preferably runs on the peripheral underside of the base plate 71 of the ring body 7.
  • this projection 710 preferably rests on the patient's skin. The skin enclosed by the annular projection 710 is thereby also fixed when the patient moves, so that the skin in the area of the electrode base 58 does not move and the measurement cannot be falsified.
  • the minimized contact area of the electrode 5, which rests on the patient's skin, ensures improved skin contact, in particular when the contact area is minimized in such a way that essentially a point support is present. In particular, body hair that would falsify a measurement is hardly trapped any more.
  • This suction electrode is also environmentally friendly and easier to dispose of because the disposable part, i.e. the electrode body, does not have any metal parts.
  • the suction electrode according to the invention has a disposable part, can be manufactured inexpensively and is nevertheless of high quality in use.

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  • Health & Medical Sciences (AREA)
  • Medical Informatics (AREA)
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  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
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Abstract

L'invention concerne une électrode d'aspiration qui comporte une partie de base (A) et un corps d'électrode (B), le corps d'électrode (B) pouvant être relié à la partie de base (A) de manière détachable et étanche à l'air. Une électrode (59) comportant un pied d'électrode ( 50, 58) fait partie intégrante soit de la partie de base (A) soit du corps d'électrode (B). Le corps d'électrode (B) présente un embout d'aspiration (4) comportant une lèvre d'étanchéité extérieure (41) destinée à être appliquée sur la peau d'un patient. L'électrode d'aspiration comporte en outre une lèvre d'étanchéité intérieure (42) périphérique qui repose de manière étanche sur une face d'enveloppe latérale du pied d'électrode (50, 58) ou sur un corps annulaire (7). La lèvre d'étanchéité intérieure (42) libère au moins en partie la face d'enveloppe au moyen de la pression axiale exercée sur la partie de base (A), de manière à réaliser une liaison d'aspiration entre l'espace intérieur (49) de l'embout d'aspiration (4) et la partie de base (A). L'électrode d'aspiration selon l'invention présente un élément à usage unique, peut être fabriquée de manière économique, tout en étant de haute qualité à l'usage.
PCT/EP2020/076402 2019-09-23 2020-09-22 Électrode d'aspiration WO2021058465A1 (fr)

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EP20772318.0A EP4033976A1 (fr) 2019-09-23 2020-09-22 Électrode d'aspiration

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EP19198972 2019-09-23
EP19198972.2 2019-09-23

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WO2021058465A1 true WO2021058465A1 (fr) 2021-04-01

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CH (1) CH715965B1 (fr)
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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116019459A (zh) * 2023-02-20 2023-04-28 淮南联合大学(安徽广播电视大学淮南分校淮南职工大学) 入耳式脑电采集装置

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0143761A1 (fr) * 1983-10-28 1985-06-05 Astra-Tech Aktiebolag Electrode fixée par dépression
EP0626820A1 (fr) * 1992-02-20 1994-12-07 Humanteknik AB Dispositif permettant de fixer un objet sur une surface par le vide
EP0729316B1 (fr) 1993-11-16 2003-06-04 Quickels Systems AB Assemblage absorbant pour électrodes biomédicales
DE20308658U1 (de) * 2003-06-03 2003-09-18 Mueller & Sebastiani Elek Gmbh Elektrodenelement für eine Saugelektrode und Saugelektrode mit einem Elektrodenelement
EP0744911B1 (fr) 1994-02-11 2004-06-30 Quickels Systems AB Element d'etancheite pour electrode biomedicale
DE10325075A1 (de) * 2003-06-03 2004-12-23 Müller & Sebastiani Elektronik GmbH Saugelektrode und Saugnapfelement für Saugelektrode
US20150374256A1 (en) * 2013-02-22 2015-12-31 Falko Skrabal Ecg device
EP3011900A1 (fr) 2014-10-24 2016-04-27 Quickels Systems AB Module d'électrode, système de succion et outil pour la surveillance de biopotentiel

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0143761A1 (fr) * 1983-10-28 1985-06-05 Astra-Tech Aktiebolag Electrode fixée par dépression
EP0143761B1 (fr) 1983-10-28 1988-03-16 Astra-Tech Aktiebolag Electrode fixée par dépression
EP0626820A1 (fr) * 1992-02-20 1994-12-07 Humanteknik AB Dispositif permettant de fixer un objet sur une surface par le vide
EP0626820B1 (fr) 1992-02-20 1999-10-27 Humanteknik AB Dispositif permettant de fixer un objet sur une surface par le vide
EP0729316B1 (fr) 1993-11-16 2003-06-04 Quickels Systems AB Assemblage absorbant pour électrodes biomédicales
EP0744911B1 (fr) 1994-02-11 2004-06-30 Quickels Systems AB Element d'etancheite pour electrode biomedicale
DE20308658U1 (de) * 2003-06-03 2003-09-18 Mueller & Sebastiani Elek Gmbh Elektrodenelement für eine Saugelektrode und Saugelektrode mit einem Elektrodenelement
DE10325075A1 (de) * 2003-06-03 2004-12-23 Müller & Sebastiani Elektronik GmbH Saugelektrode und Saugnapfelement für Saugelektrode
US20150374256A1 (en) * 2013-02-22 2015-12-31 Falko Skrabal Ecg device
EP3011900A1 (fr) 2014-10-24 2016-04-27 Quickels Systems AB Module d'électrode, système de succion et outil pour la surveillance de biopotentiel

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116019459A (zh) * 2023-02-20 2023-04-28 淮南联合大学(安徽广播电视大学淮南分校淮南职工大学) 入耳式脑电采集装置

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EP4033976A1 (fr) 2022-08-03

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